(29 days)
Not Found
No
The device is a chemical indicator that changes color based on exposure to steam sterilization parameters, which is a purely physical/chemical reaction, not involving AI/ML.
No
This device is an integrating indicator used to monitor the effectiveness of steam sterilization processes for medical instruments. It does not treat or diagnose any medical condition, nor does it affect the structure or function of the body. Its purpose is to ensure that other medical devices are properly sterilized.
No
Explanation: This device is an integrating indicator used to monitor critical parameters of a steam sterilization cycle. It determines if sterilization conditions have been met, but it does not diagnose a medical condition or disease in a patient.
No
The device is a physical strip with a chemical pellet that melts and migrates based on exposure to steam sterilization parameters. It is a hardware device, not software.
Based on the provided information, the Getinge Assured MI Steam Migrating Integrator strip is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The device is intended to monitor the critical parameters of a steam sterilization cycle within a pack, pouch, tray, or container. Its purpose is to indicate whether the physical conditions required for sterilization have been met.
- Mechanism of Action: It works by a chemical pellet melting and migrating based on exposure to steam, temperature, and time. This is a physical/chemical reaction, not a test performed on a biological sample.
- No Biological Sample: IVD devices are designed to examine specimens derived from the human body (or sometimes animals) to provide information for diagnosis, monitoring, or screening. This device does not interact with any biological sample.
- Monitoring a Process: The device is monitoring a physical process (sterilization), not analyzing a biological state or condition.
Therefore, the Getinge Assured MI Steam Migrating Integrator strip is a sterilization process indicator, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Getinge Assured MI Steam Migrating Integrator strip is an internal pack integrating indicator designed to react to critical process parameters of a steam sterilization cycle within a stated tolerance. The integrating indicator is intended to be placed in each pack, pouch, tray, or container to function as an independent monitor of critical parameters for the following sterilization cycles:
Steam Sterilization Cycles:
250°F/121°C, 30 minutes Gravity
270°F/132°C, 10 minutes Dynamic Air Removal
270°F/132°C, 4 minutes Dynamic Air Removal
270°F/132°C, 15 minutes Gravity
273°F/134°C, 3 minutes Dynamic Air Removal
273°F/134°C, 4 minutes Dynamic Air Removal
275°F/135°C, 3 minutes Dynamic Air Removal
275°F/135°C, 10 minutes Gravity
Steam Sterilization Cycles Immediate Use Steam Sterilization (IUSS):
270°F/132°C, 4 minutes Dynamic Air Removal IUSS
270°F/132°C, 3 minutes Gravity IUSS
270°F/132°C, 10 minutes Gravity IUSS
275°F/135°C, 3 minutes Dynamic Air Removal IUSS
275°F/135°C, 3 minutes Gravity IUSS
275°F/135°C, 10 minutes Gravity IUSS
Stated values (as determined in a steam resistometer):
30 minutes at 121°C
9.1 minutes at 128°C
3.3 minutes at 132°C
2.4 minutes at 134°C
1.5 minutes at 135°C
Product codes (comma separated list FDA assigned to the subject device)
JOJ
Device Description
The Getinge Assured MI Steam Migrating Integrator Strip is used in each pack to be sterilized to monitor exposure to critical process parameters of steam sterilization. The Getinge Assured MI meets the performance specifications for a Type 5 Integrating Indicator as defined by ANSI/AAMI/ISO 11140-1:2014.
It consists of a paper wick and a steam sensitive chemical pellet containing blue colored dye. A pellet is held within a pocket located at one end of an aluminum foil tape base. The foil tape base is adhered to a film material that has been bonded with a paper label. During steam sterilization, the Integrating Indicator pellet will melt and migrate into the PASS window when the specified critical parameters of steam sterilization have been met.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing was conducted to verify that the proposed Getinge Assured MI Steam Migrating Integrator meets the requirements for integrating indicators in accordance with the Guidance for Industry and FDA Staff: Premarket Notification [510(k)] Submissions for Chemical Indicators for integrating indicators as well as ANSI/AAMI/ISO 11140-1:2014.
Key results: All tests passed.
Steam Resistometer (BIER vessel) Testing:
- Pass result at the stated value for each temperature claimed:
- 30 Minutes at 121°C
- 3.8 minutes at 132°C, 4.1 minutes at 132°C, 4.0 minutes at 132°C
- 2.1 minutes at 134°C, 2.2 minutes at 134°C, 2.4 minutes at 134°C
- 1.7 minutes at 135°C, 2.0 minutes at 135°C, 1.8 minutes at 135°C
- Failing Result at 15% less time of SV for each temperature claimed: PASS
- Failing Result at 1°C less for each temperature claimed: PASS
Hospital Steam Sterilizer Testing:
- 100% samples passing under passing conditions for each cycle: PASS
- 100% samples failing under failing conditions for each cycle: PASS
Dry Heat Testing:
- Failing result when exposed to dry heat alone for 30 minutes (±1 minute) at 140°C (±2°C): PASS
Side-by-side testing of the biological indicator and integrator in steam resistometer:
- The integrator does not reach its endpoint before the biological indicator is inactivated: PASS
Offset/Transference:
- The indicator agent shall not offset or bleed, penetrate the substrate to which it is applied, or materials in which it is in contact before, during or after the sterilization cycles for which it is designed: PASS
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.2800 Sterilization process indicator.
(a)
Biological sterilization process indicator —(1)Identification. A biological sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of a known number of microorganisms, of known resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization.(2)
Classification. Class II (performance standards).(b)
Physical/chemical sterilization process indicator —(1)Identification. A physical/chemical sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process. The adequacy of the sterilization conditions as measured by these parameters is indicated by a visible change in the device.(2)
Classification. Class II (performance standards).
0
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October 15, 2024
SteriTec Products Mfg. (a Getinge Group Company) % Barb Smith Principal Regulatory Affairs Specialist Getinge 45 Barbour Pond Drive Wayne, New Jersey 07470
Re: K242795
Trade/Device Name: Getinge Assured MI Steam Migrating Integrator Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: JOJ Dated: September 16, 2024 Received: September 16, 2024
Dear Barb Smith:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory
2
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Image /page/2/Picture/3 description: The image shows the text "Stephen A. Anisko -S" in a simple, sans-serif font. The text is arranged in two lines, with "Stephen A." on the first line and "Anisko -S" on the second line. The text is black against a white background, and the letter "S" is slightly offset to the right.
Digitally signed by Stephen A. Anisko -S Date: 2024.10.15 15:28:23 -04'00'
for: Christopher Dugard Assistant Director DHT4C: Division of Infection Control Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K242795
Device Name Getinge Assured MI Steam Migrating Integrator
Indications for Use (Describe)
The Getinge Assured MI Steam Migrating Integrator strip is an internal pack integrating indicator designed to react to critical process parameters of a steam sterilization cycle within a stated tolerance. The integrating indicator is intended to be placed in each pack, pouch, tray, or container to function as an independent monitor of critical parameters for the following sterilization cycles:
Steam Sterilization Cycles: 250°F/121°C, 30 minutes Gravity 270°F/132°C, 10 minutes Dynamic Air Removal 270°F/132°C, 4 minutes Dynamic Air Removal 270°F/132°C, 15 minutes Gravity 273°F/134°C, 3 minutes Dynamic Air Removal
273°F/134°C, 4 minutes Dynamic Air Removal 275°F/135°C, 3 minutes Dynamic Air Removal 275°F/135°C, 10 minutes Gravity
Steam Sterilization Cycles Immediate Use Steam Sterilization (IUSS): 270°F/132°C, 4 minutes Dynamic Air Removal IUSS 270°F/132°C, 3 minutes Gravity IUSS 270°F/132°C, 10 minutes Gravity IUSS 275°F/135°C, 3 minutes Dynamic Air Removal IUSS 275°F/135°C, 3 minutes Gravity IUSS 275°F/135°C, 10 minutes Gravity IUSS
Stated values (as determined in a steam resistometer):
30 minutes at 121°C 9.1 minutes at 128°C 3.3 minutes at 132°C 2.4 minutes at 134°C 1.5 minutes at 135°C
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
4
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5
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510(k) Summary for the Getinge Assured MI Steam Migrating Integrator K242795
Page 1 of 6
510(k) Summary K242795
Date Prepared: October 15, 2024
Applicant Information
SteriTec Products Manufacturing CO INC (a Getinge Group company) 74 Inverness Drive East Englewood, CO 80112 U.S. Ph: 303-660-4201
Contact: Barb Smith Principal Regulatory Affairs Specialist Ph: 585-370-6101 e-mail: barb.smith@getinge.com
-
- Device Name
| Trade Name: | Getinge Assured MI Steam Migrating Integrator |
|---|---|
| Device Classification: | Class II |
| Common/Usual Name: | Indicator, physical/chemical sterilization process |
| Classification Name: | Indicator, physical/chemical sterilization process (21 CFR 880.2800, JOJ) |
-
- Predicate Device
Getinge Assured MI Steam Migrating Integrator (K200252). SteriTec Products, Manufacturing Co. Inc.
- Predicate Device
3. Description of Device
The Getinge Assured MI Steam Migrating Integrator Strip is used in each pack to be sterilized to monitor exposure to critical process parameters of steam sterilization. The Getinge Assured MI meets the performance specifications for a Type 5 Integrating Indicator as defined by ANSI/AAMI/ISO 11140-1:2014.
It consists of a paper wick and a steam sensitive chemical pellet containing blue colored dve. A pellet is held within a pocket located at one end of an aluminum foil tape base. The foil tape base is adhered to a film material that has been bonded with a paper label. During steam sterilization, the Integrating Indicator pellet will melt and migrate into the PASS window when the specified critical parameters of steam sterilization have been met.
6
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510(k) Summary for the Getinge Assured MI Steam Migrating Integrator K242795
Page 2 of 6
4. Intended Use/Indications for Use:
The Getinge Assured MI Steam Migrating Integrator strip is an internal pack integrating indicator designed to react to critical process parameters of a steam sterilization cycle within a stated tolerance. The integrating indicator is intended to be placed in each pack, pouch, tray, or container to function as an independent monitor of critical parameters for the following sterilization cycles:
Steam Sterilization Cycles:
250°F/121°C, 30 minutes Gravity 270°F/132°C, 10 minutes Dynamic Air Removal 270°F/132°C, 4 minutes Dynamic Air Removal 270°F/132°C, 15 minutes Gravity 273°F/134°C, 3 minutes Dynamic Air Removal 273°F/134°C, 4 minutes Dynamic Air Removal 275°F/135°C, 3 minutes Dynamic Air Removal 275°F/135°C, 10 minutes Gravity
Steam Sterilization Cycles Immediate Use Steam Sterilization (IUSS):
270°F/132°C, 4 minutes Dynamic Air Removal IUSS
270°F/132°C, 3 minutes Gravity IUSS 270°F/132°C, 10 minutes Gravity IUSS
275°F/135°C, 3 minutes Dynamic Air Removal IUSS
275°F/135°C, 3 minutes Gravity IUSS
275°F/135°C, 10 minutes Gravity IUSS
Stated values (as determined in a steam resistometer):
30 minutes at 121°C 9.1 minutes at 128°C 3.3 minutes at 132°C 2.4 minutes at 134°C 1.5 minutes at 135°C
The intended use of the subject device has only been modified with the addition of sterilization cycles, from the referenced predicate device. The monitoring of the following cycles has been added:
- 10 minutes at 132°C Dynamic Air Removal .
- 3 minutes at 134°C Dynamic Air Removal .
- 4 minutes at 134°C Dynamic Air Removal. .
5. Technological Characteristics
The chart below compares the technological characteristics of the subject device, to that of the predicate device:
7
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510(k) Summary for the Getinge Assured MI Steam Migrating Integrator K242795
Page 3 of 6
| Feature | Predicate Device (K200252) | Modified/Subject Device (K242795) | Comparison |
|---|---|---|---|
| Intended | |||
| Use/Indications | |||
| for Use | The Getinge Assured MI Steam | ||
| Migrating Integrator strip is an internal | |||
| pack integrating indicator designed to | |||
| react to critical process parameters of a | |||
| steam sterilization cycle within a stated | |||
| tolerance. The integrating indicator is | |||
| intended to be placed in each pack, | |||
| pouch, tray, or container to function as | |||
| an independent monitor of critical | |||
| parameters for the following | |||
| sterilization cycles: |
Steam Sterilization Cycles:
250°F/121°C, 30 minutes Gravity 270°F/132°C, 4 minutes Dynamic
Air Removal 270°F/132°C, 15 minutes Gravity 275°F/135°C, 3 minutes Dynamic
Air Removal 275°F/135°C, 10 minutes Gravity Steam Sterilization Cycles (IUSS): 270°F/132°C, 4 minutes Dynamic
Air Removal 270°F/132°C, 3 minutes Gravity 270°F/132°C, 10 minutes Gravity 275°F/135°C, 3 minutes Dynamic
Air Removal 275°F/135°C, 3 minutes Gravity 275°F/135°C, 10 minutes Gravity Stated values (as determined in a
steam resistometer): 30 minutes at 121°C 9.1 minutes at 128°C 3.3 minutes at 132°C 1.5 minutes at 135°C | The Getinge Assured MI Steam Migrating
Integrator strip is an internal pack
integrating indicator designed to react to
critical process parameters of a steam
sterilization cycle within a stated tolerance.
The integrating indicator is intended to be
placed in each pack, pouch, tray, or
container to function as an independent
monitor of critical parameters for the
following sterilization cycles:
Steam Sterilization Cycles: 250°F/121°C, 30 minutes Gravity 270°F/132°C, 10 minutes Dynamic Air
Removal 270°F/132°C, 4 minutes Dynamic Air
Removal 270°F/132°C, 15 minutes Gravity 273°F/134°C, 3 minutes Dynamic Air
Removal 273°F/134°C, 4 minutes Dynamic Air
Removal 275°F/135°C, 3 minutes Dynamic Air
Removal 275°F/135°C, 10 minutes Gravity Steam Sterilization Cycles (IUSS): 270°F/132°C, 4 minutes Dynamic Air
Removal IUSS 270°F/132°C, 3 minutes Gravity IUSS 270°F/132°C, 10 minutes Gravity IUSS 275°F/135°C, 3 minutes Dynamic Air
Removal IUSS 275°F/135°C, 3 minutes Gravity IUSS 275°F/135°C, 10 minutes Gravity IUSS Stated values (as determined in a steam
resistometer): 30 minutes at 121°C 9.1 minutes at 128°C 3.3 minutes at 132°C 2.4 minutes at 134°C 1.5 minutes at 135°C | The Intended Use of proposed
modified device is the same. This
submission proposes the
monitoring of additional exposure
temperatures and times: 10 minutes at 132°C
Dynamic Air Removal 3 minutes at 134°C Dynamic
Air Removal 4 minutes at 134°C Dynamic
Air Removal |
| Device Design | A paper wick and a steam sensitive
chemical pellet containing blue colored
dye. A pellet is held within a pocket
located at one end of an aluminum foil
tape base. The foil tape base is adhered
to a film material that has been bonded
with a paper label. During steam
sterilization, the integrating indicator
pellet will melt and migrate into the
PASS window when the specified
critical parameters of steam | A paper wick and a steam sensitive
chemical pellet containing blue colored dye.
A pellet is held within a pocket located at
one end of an aluminum foil tape base. The
foil tape base is adhered to a film material
that has been bonded with a paper label.
During steam sterilization, the integrating
indicator pellet will melt and migrate into
the PASS window when the specified
critical parameters of steam sterilization
have been met. | Same |
| | sterilization have been met. | | |
| Sterilization
methods and
cycles | Steam Sterilization Cycles:
• 250°F/121°C, 30 minutes Gravity
• 270°F/132°C, 4 minutes Dynamic
Air Removal
• 270°F/132°C, 15 minutes Gravity
• 275°F/135°C, 3 minutes Dynamic
Air Removal
• 275°F/135°C, 10
minutes Gravity
Steam Sterilization Cycles (IUSS):
• 270°F/132°C, 4 minutes Dynamic
Air Removal
• 270°F/132°C, 3 minutes Gravity
• 270°F/132°C, 10 minutes Gravity
• 275°F/135°C, 3 minutes Dynamic
Air Removal
• 275°F/135°C, 3 minutes Gravity
• 275°F/135°C, 10 minutes Gravity | Steam Sterilization Cycles:
• 250°F/121°C, 30 minutes Gravity
• 270°F/132°C, 10 minutes Dynamic Air
Removal
• 270°F/132°C, 4 minutes Dynamic Air
Removal
• 270°F/132°C, 15 minutes Gravity
• 273°F/134°C, 3 minutes Dynamic Air
Removal
• 273°F/134°C, 4 minutes Dynamic Air
Removal
• 275°F/135°C, 3 minutes Dynamic Air
Removal
• 275°F/135°C, 10 minutes Gravity
Steam Sterilization Cycles (IUSS):
• 270°F/132°C, 4 minutes Dynamic Air
Removal IUSS
• 270°F/132°C, 3 minutes Gravity IUSS
• 270°F/132°C, 10 minutes Gravity IUSS
• 275°F/135°C, 3 minutes Dynamic Air
Removal IUSS
• 275°F/135°C, 3 minutes Gravity IUSS
• 275°F/135°C, 10 minutes Gravity IUSS | Same with the addition of cycles:
• 10 minutes at 132°C
Dynamic Air Removal
• 3 minutes at 134°C Dynamic
Air Removal
• 4 minutes at 134°C Dynamic
Air Removal |
| Indicator Agent | Proprietary | Proprietary | Same |
| Endpoint
Specifications | The endpoint is determined by
migration of the steam sensitive pellet,
carrying the blue dye, to an area
marked PASS on the indicator.
Endpoint is reached at the stated value
(SV) for each claimed temperature.
Endpoint is not reached at the stated
value - 15% time and/or 1°C. | The endpoint is determined by migration of
the steam sensitive pellet, carrying the blue
dye, to an area marked PASS on the
indicator. Endpoint is reached at the stated
value (SV) for each claimed temperature.
Endpoint is not reached at the stated value -
15% time and/or 1°C. | Same |
| Shelf Life | 5 Years | 5 Years | Same |
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510(k) Summary for the Getinge Assured MI Steam Migrating Integrator K242795
Page 4 of 6
6. Non-Clinical Performance Testing
Performance testing was conducted to verify that the proposed Getinge Assured MI Steam Migrating Integrator meets the requirements for integrating indicators in accordance with the Guidance for Industry and FDA Staff: Premarket Notification [510(k)] Submissions for Chemical Indicators for integrating indicators as well as ANSI/AAMI/ISO 11140-1:2014.
The following table summarizes the performance testing that was completed, with acceptance criteria and results to demonstrate that the Getinge Assured MI Steam Migrating Integrator met the requirements of its pre-determined acceptance criteria in its claimed intended steam sterilization cycles.
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510(k) Summary for the Getinge Assured MI Steam Migrating Integrator K242795
Page 5 of 6
| Performance Testing of 3
manufactured lots of
| Integrator | Pre-Determined Acceptance Criteria | Results |
|---|---|---|
| Steam Resistometer (BIER | ||
| vessel) Testing: | ||
| (According to ANSI/AAMI/ISO | ||
| 11140-1:2014 Sterilization of health | ||
| care products - Chemical indicators |
- Part 1: General requirements and
Premarket Notification [510(k)]
Submissions for Chemical
Indicators - Guidance for Industry
and FDA Staff.) | Pass result at the stated value for each
temperature claimed: - 30 Minutes at 121°C
- 3.8 minutes at 132°C, 4.1 minutes at 132°C,
4.0 minutes at 132°C - 2.1 minutes at 134°C, 2.2 minutes at 134°C,
2.4 minutes at 134°C - 1.7 minutes at 135°C, 2.0 minutes at 135°C,
1.8 minutes at 135°C, | PASS |
| | Failing Result at 15% less time of SV for each
temperature claimed | PASS |
| | Failing Result at 1°C less for each temperature
claimed | PASS |
| Hospital Steam Sterilizer
Testing: | 100% samples passing under passing conditions
for each cycle | PASS |
| (To demonstrate pass/fail results
from an actual sterilization cycle
used in a health care facility
according to Premarket Notification
[510(k)] Submissions for Chemical
Indicators - Guidance for Industry
and FDA Staff) | 100% samples failing under failing conditions for
each cycle | PASS |
| Dry Heat Testing:
(According to ANSI/AAMI/ISO
11140-1:2014 Sterilization of health
care products - Chemical indicators - Part 1: General requirements and
Premarket Notification [510(k)]
Submissions for Chemical
Indicators - Guidance for Industry
and FDA Staff) | Failing result when exposed to dry heat alone for
30 minutes (±1 minute) at 140°C (±2°C) | PASS |
| Side-by-side testing of the
biological indicator and
integrator in steam
resistometer:
(As specified in Premarket
Notification [510(k)] Submissions
for Chemical Indicators - Guidance
for Industry and FDA Staff) | The integrator does not reach its endpoint before
the biological indicator is inactivated | PASS |
| Offset/Transference:
(According to ANSI/AAMI/ISO
11140-1:2014 Sterilization of health
care products - Chemical indicators - Part 1: General requirements.) | The indicator agent shall not offset or bleed,
penetrate the substrate to which it is applied, or
materials in which it is in contact before, during
or after the sterilization cycles for which it is
designed | PASS |
10
Image /page/10/Picture/0 description: The image shows the word "Steritec" in a bold, sans-serif font. The word is written in black and is set against a white background. A horizontal line underlines the word, adding a sense of stability to the design. The overall design is simple and modern.
510(k) Summary for the Getinge Assured MI Steam Migrating Integrator K242795
Page 6 of 6
7. Conclusion:
Based on the results from the performance testing per the Guidance for Industry and FDA Staff: Premarket Notification [510(k)] Submissions for Chemical Indicators for integrating indicators as well as ANSI/AAMI/ISO 11140- 1:2014, the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device (K200252), Class II Indicator, physical/chemical sterilization process (21 CFR 880.2800), JOJ.